Smoking Cessation
Conditions
Brief summary
Imbio is developing a Smoking Cessation Report (Report) that includes data analysis from a CT lung cancer screening exam. This randomized controlled (RCT) trial will clinically validate the Report's effectiveness at motivating smokers to call a Quitline.
Detailed description
Imbio is developing a Smoking Cessation Report (Report) that includes data analysis from a CT lung cancer screening exam. This randomized controlled (RCT) trial will clinically validate the Report's impact on: (a) Lung screening participants' motivation to make a quit attempt by calling a Quitline, and (b) the effectiveness of a 45-minute telephone smoking cessation counseling session for motivating an actual quit attempt and abstinence. The RCT will enroll approximately 400 randomly selected participants from lung screening programs at HealthPartners and University of Michigan. Participants will be randomly assigned to one of four conditions: 1) Usual Care + quitline phone number (created specifically for the trial and maintained for the length of the trial); 2) Usual Care + Report (Report will list Quitline number) 3) Usual Care + Counseling, or 4) Usual Care + Report + Counseling. Follow up assessment calls will be conducted with participants at three weeks, three months, and six months following the mailing of the report.
Interventions
DEVICEImbio Smoking Cessation Report
Research coordinators at the University of Michigan and HealthPartners will be provided access to the research version of LDA via an Imbio website. Following consent and lung screen, research coordinators will manually upload the study participants' images and download a resulting Report. Radiologists have been designated at both sites to review and approve the Report prior to mailing to participants. The Report will include information including the percent of damaged lung volume.
BEHAVIORALSmoking Cessation Counseling
45 minute counseling session with a tobacco treatment specialist.
OTHERUsual Care
Usual Care for Lung Cancer Screening patients.
Sponsors
National Cancer Institute (NCI)
University of Michigan
Mayo Clinic
HealthPartners Institute
University of Minnesota
Imbio
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
University of Minnesota Office of Measurements Services will administer follow up calls to assess outcomes. Callers will be blinded to the arm to which the patients were assigned.
Eligibility
Sex/Gender
ALL
Age
55 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 30-pack year smoking history * currently smoke OR quit within the last 15 years and a category 1 or 2 Lung-RADS scan
Exclusion criteria
* current use of smoking cessation medications * scan read as a category 3, 4A, 4B or 4X in Lung-RADS * unstable medical or psychiatric conditions * current alcohol or drug use disorder * past-month suicidal ideation * past-year suicide attempt
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Report's Impact on Calling a Quitline Number | 3 weeks after intervention. | This outcome will be measured by whether the participant calls the Quitline number provided to them. \*\*\*Given logistical complexities, it was never the intention to measure this outcome on a participant level, but rather to compare the arms as different groups to see if there is a difference in the number of calls received for each groups Quitline number, which was automatically monitored. Unfortunately, it because apparent that the monitored Quitline numbers were subject to many robocalls and that data because too unreliable to be analyzed. |
| Report's Impact Making a Quit Attempt Measured Via Follow-up Phone Call | 3 weeks after intervention | This outcome will be measured by the participants' motivation to make a quit attempt and abstain from smoking. The question asked was: How ready are you to quit smoking? Answer options include: 1. Not at all ready 2. Slightly ready 3. Moderately ready 4. Very ready |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Usual Care includes a lung cancer screening CT exam. Following the screen, a radiologist will analyze the CT scan image and send the results to the patient's Primary Care Physician (PCP). If the scan is read as a category 1 or 2 in the Lung Reporting and Data System (Lung-RADS), patients are provided a letter in the mail with their results. If the scan is read as a category 3, 4A, 4B, or 4X in Lung-RADS the patient will be contacted by their primary care physician's office and told to schedule a follow up appointment. Either in the letter or at the follow up appointment, patients will be given a Quitline number created specifically for this trial and maintained for the duration.
Usual Care: Usual Care for Lung Cancer Screening patients. | 79 |
| Usual Care + Imbio Smoking Cessation Report In this arm, patients will receive the Usual Care described above and will additionally be provided with the Report. In this arm, the Report will provide the Quitline number.
Imbio Smoking Cessation Report: Research coordinators at the University of Michigan and HealthPartners will be provided access to the research version of LDA via an Imbio website. Following consent and lung screen, research coordinators will manually upload the study participants' images and download a resulting Report. Radiologists have been designated at both sites to review and approve the Report prior to mailing to participants. The Report will include information including the percent of damaged lung volume.
Usual Care: Usual Care for Lung Cancer Screening patients. | 80 |
| Usual Care + Counseling In addition to the Usual Care described above, patients in this arm will participate in a 45 minute smoking cessation counseling session. Approximately three Tobacco Treatment Specialists will be trained to ensure consistent counseling methodology. Counselors will utilize a patient centered approach grounded in Motivational Interviewing skills to elicit perceived benefits for stopping smoking and to enhance self-efficacy for stopping. A major emphasis of a call is to enroll the caller in formal cessation programs and/or convince them to use FDA approved medication as part of a quit attempt. Study participants who desire further smoking cessation support after their session will be connected with the appropriate organization.
Smoking Cessation Counseling: 45 minute counseling session with a tobacco treatment specialist.
Usual Care: Usual Care for Lung Cancer Screening patients. | 82 |
| Usual Care + Imbio Smoking Cessation Report + Counseling In addition to the Usual Care and Counseling described above, patients in this arm will also receive the Report.
Imbio Smoking Cessation Report: Research coordinators at the University of Michigan and HealthPartners will be provided access to the research version of LDA via an Imbio website. Following consent and lung screen, research coordinators will manually upload the study participants' images and download a resulting Report. Radiologists have been designated at both sites to review and approve the Report prior to mailing to participants. The Report will include information including the percent of damaged lung volume.
Smoking Cessation Counseling: 45 minute counseling session with a tobacco treatment specialist.
Usual Care: Usual Care for Lung Cancer Screening patients. | 80 |
| Total | 321 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 32 | 30 | 30 | 39 |
Baseline characteristics
| Characteristic | Usual Care + Imbio Smoking Cessation Report | Usual Care + Counseling | Usual Care + Imbio Smoking Cessation Report + Counseling | Total | Usual Care |
|---|---|---|---|---|---|
| Age, Continuous | 65 years STANDARD_DEVIATION 6 | 65 years STANDARD_DEVIATION 5.45 | 65 years STANDARD_DEVIATION 6 | 65 years STANDARD_DEVIATION 6 | 67 years STANDARD_DEVIATION 6 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants | — |
| Region of Enrollment United States | 80 participants | 82 participants | 80 participants | 321 participants | 79 participants |
| Sex: Female, Male Female | 38 Participants | 52 Participants | 38 Participants | 166 Participants | 38 Participants |
| Sex: Female, Male Male | 42 Participants | 30 Participants | 42 Participants | 155 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 79 | 0 / 80 | 0 / 82 | 0 / 80 |
| other Total, other adverse events | 0 / 79 | 0 / 80 | 0 / 82 | 0 / 80 |
| serious Total, serious adverse events | 0 / 79 | 0 / 80 | 0 / 82 | 0 / 80 |
Outcome results
Primary
Report's Impact Making a Quit Attempt Measured Via Follow-up Phone Call
This outcome will be measured by the participants' motivation to make a quit attempt and abstain from smoking. The question asked was: How ready are you to quit smoking? Answer options include: 1. Not at all ready 2. Slightly ready 3. Moderately ready 4. Very ready
Time frame: 6 months after intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Report's Impact Making a Quit Attempt Measured Via Follow-up Phone Call | 2.85 score on a scale | Standard Deviation 0.88 |
| Usual Care + Imbio Smoking Cessation Report | Report's Impact Making a Quit Attempt Measured Via Follow-up Phone Call | 3.00 score on a scale | Standard Deviation 0.93 |
| Usual Care + Counseling | Report's Impact Making a Quit Attempt Measured Via Follow-up Phone Call | 2.80 score on a scale | Standard Deviation 0.93 |
| Usual Care + Imbio Smoking Cessation Report + Counseling | Report's Impact Making a Quit Attempt Measured Via Follow-up Phone Call | 3.07 score on a scale | Standard Deviation 0.96 |
Primary
Report's Impact Making a Quit Attempt Measured Via Follow-up Phone Call
This outcome will be measured by the participants' motivation to make a quit attempt and abstain from smoking. The question asked was: How ready are you to quit smoking? Answer options include: 1. Not at all ready 2. Slightly ready 3. Moderately ready 4. Very ready
Time frame: 3 weeks after intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Report's Impact Making a Quit Attempt Measured Via Follow-up Phone Call | 2.73 score on a scale | Standard Deviation 0.84 |
| Usual Care + Imbio Smoking Cessation Report | Report's Impact Making a Quit Attempt Measured Via Follow-up Phone Call | 3.15 score on a scale | Standard Deviation 0.9 |
| Usual Care + Counseling | Report's Impact Making a Quit Attempt Measured Via Follow-up Phone Call | 2.92 score on a scale | Standard Deviation 0.87 |
| Usual Care + Imbio Smoking Cessation Report + Counseling | Report's Impact Making a Quit Attempt Measured Via Follow-up Phone Call | 2.97 score on a scale | Standard Deviation 0.92 |
Primary
Report's Impact Making a Quit Attempt Measured Via Follow-up Phone Call
This outcome will be measured by the participants' motivation to make a quit attempt and abstain from smoking. The question asked was: How ready are you to quit smoking? Answer options include: 1. Not at all ready 2. Slightly ready 3. Moderately ready 4. Very ready
Time frame: 3 months after intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Report's Impact Making a Quit Attempt Measured Via Follow-up Phone Call | 2.75 score on a scale | Standard Deviation 0.92 |
| Usual Care + Imbio Smoking Cessation Report | Report's Impact Making a Quit Attempt Measured Via Follow-up Phone Call | 3.08 score on a scale | Standard Deviation 0.92 |
| Usual Care + Counseling | Report's Impact Making a Quit Attempt Measured Via Follow-up Phone Call | 2.61 score on a scale | Standard Deviation 0.98 |
| Usual Care + Imbio Smoking Cessation Report + Counseling | Report's Impact Making a Quit Attempt Measured Via Follow-up Phone Call | 3.07 score on a scale | Standard Deviation 0.9 |
Primary
Report's Impact on Calling a Quitline Number
This outcome will be measured by whether the participant calls the Quitline number provided to them. \*\*\*Given logistical complexities, it was never the intention to measure this outcome on a participant level, but rather to compare the arms as different groups to see if there is a difference in the number of calls received for each groups Quitline number, which was automatically monitored. Unfortunately, it because apparent that the monitored Quitline numbers were subject to many robocalls and that data because too unreliable to be analyzed.
Time frame: 3 weeks after intervention.
Population: Given logistical complexities, it was never the intention to measure this outcome on a participant level, but rather to compare the arms as different groups to see if there is a difference in the number of calls received for each groups Quitline number, which was automatically monitored. Unfortunately, it because apparent that the monitored Quitline numbers were subject to many robocalls and that data because too unreliable to be analyzed.
Primary
Report's Impact on Calling a Quitline Number
This outcome will be measured by whether the participant calls the Quitline number provided to them.
Time frame: 3 months after intervention
Population: \*\*\*Given logistical complexities, it was never the intention to measure this outcome on a participant level, but rather to compare the arms as different groups to see if there is a difference in the number of calls received for each groups Quitline number, which was automatically monitored. Unfortunately, it because apparent that the monitored Quitline numbers were subject to many robocalls and that data because too unreliable to be analyzed.
Primary
Report's Impact on Calling a Quitline Number
This outcome will be measured by whether the participant calls the Quitline number provided to them.
Time frame: 6 months after intervention
Population: \*\*\*Given logistical complexities, it was never the intention to measure this outcome on a participant level, but rather to compare the arms as different groups to see if there is a difference in the number of calls received for each groups Quitline number, which was automatically monitored. Unfortunately, it because apparent that the monitored Quitline numbers were subject to many robocalls and that data because too unreliable to be analyzed.